Nerve and muscle stimulation are used to treat a variety of medical conditions such as to reduce pain and to assist muscle and joint rehabilitation. Nerve stimulation has also been used for decades to control bladder function. Today, nerve stimulation is used to manage dysfunctions of the central nervous system as well as end organ dysfunction through modulation of relevant peripheral nerve activity. Various approaches to gastrointestinal and bladder neuromodulation have been studied with stimulation of the vagus, pudendal, sacral, and tibial nerves that have proven to be effective in controlling end organ function.
One problem distributing medical devices is that the manufacturers of the devices have trouble implementing into the sale of the devices a financially viable and profitable business model. This is particularly true with respect to medical devices that do not require specialized replacement parts associated with each use. In most cases, devices of this type are sold with all revenue frontloaded into the original sale of the device. The medical provider, office or hospital must pay for all future use of the device on the day of purchase. In other words, the manufacture sells the device to a healthcare customer for a fixed price and then receives no additional income from the customer once the device is sold unless the customer purchases another device. Such devices are numerous and include, for example, nerve stimulating systems, muscle stimulating devices, laser-therapy devices and other radiologic, sonographic, fetal monitoring, diagnostic and therapeutic devices, both clinical and laboratory in nature.
In order for a manufacturer to realize, financially, the lifetime value of any medical device, that value is typically paid at the time of sale of the device. This creates a notable burden of the end user to prepay a sizable percentage of the revenue hoped to be generated by the delivery of services with that device. Rising prices and an uncertain economy has created real obstacles to the purchase of new and effective medical devices. One solution has been for manufacturers to design and incorporate non-reusable components into newer devices to generate ongoing revenue, allowing the original cost of the device to be set at a lower price point. The balance is replaced by the ongoing sales of the non-reusable items by the manufacturer to the end user. For example, U.S. Pat. No. 7,536,226 and U.S. Pat. No. 8,046,082 relate to a nerve stimulation device for treating incontinence where a reusable lead wire system as described in U.S. Pat. No. 6,493,588 was converted into a single lead use system. In other words, manufacturers have resorted to creating specialized replacement parts even when none are necessary in an attempt to artificially create a recurring revenue stream from the sale of the device. However, this results in unnecessary waste when the non-reusable components could be designed to be longer lasting. Additionally, the manufacturer runs the risk of competitors entering the market with their own replacement components for the manufacturer's device.
What is needed therefore is a payment system that can be easily incorporated into medical devices providing the ability to charge a healthcare provider/device owner for each treatment session. This allows a lower initial sale price of the device that is supplemented with a recurring revenue stream so long as the device is used. The purchaser of the device also is benefited with lower initial costs, simplifying their own financials, stretching out payment for and allowing greater access to new technology. The purchaser is provided the ability to pay for the device with revenue actually generated by the device usage. The patients benefit by greater access to new therapies or therapy delivered by newer, more effective or more efficient devices.
Additionally, owners of certain devices may wish to implement the payment system into existing devices to recoup their investment in the device and provide a simple and efficient payment system for their patients.